Protocol/serial number

Study information

Scientific title

Acronym

CompARE Trial

Study hypothesis

Pragmatic phase III open-label randomised controlled trial using an efficient, adaptive, multi-arm multi-stage (MAMS) design, with an integrated qualitative recruitment investigation aiming to optimise recruitment and consenting, to determine the optimum treatment of intermediate and high-risk OPC with the aim of improving survival outcomes without significantly worsening toxicity, Quality of Life (QoL) or swallowing function, compared to the current standard treatment of chemoradiotherapy.

Ethics approval

West Midlands - Solihull, 27/11/2014, ref: 14/WM/1170

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Intervention type

Drug

Phase

Phase III

Drug names

Primary outcome measures

1. Definitive (efficacy) endpoint: Overall Survival (OS) - Interval in whole days between the date of randomisation and the date of death from any cause2. Interim outcome measure (activity stages): Disease Free Survival (DFS) - Interval between the date of randomisation and the date of death or the 1st documented relapse

Secondary outcome measures

1. Total number of acute (<3 months post-treatment) and late (up to 2 years) severe (grade 3-5) toxicity events at 2 years post randomisation, measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.02. Overall and head and neck specific QoL at 2 years post randomisation, using the European Organisation for Research and Treatment of Cancer (EORTC) C30 and H&N35 Questionnaires3. Swallowing outcomes using M.D. Anderson Dysphagia Inventory (MDADI) Questionnaire at 24 months and percutaneous endoscopic gastrostomy (PEG) utilisation rates at 1 year4. Cost effectiveness using EuroQol Group (EQ-5D), patient diaries and primary and secondary resource utilisation data5. Surgical complication rates in each arm

Participant type

Age group

Gender

Target number of participants

Participant exclusion criteria

1. Low­ risk OPSCC defined as:1.1. HPV+ OPC non­smokers or1.2. HPV+ OPC smokers <10 pack years or 1.3. HPV+ OPC smokers >10 pack years with N0­2A nodal disease2. Unfit for surgery or chemoradiotherapy regimens3. Creatinine Clearance <50ml/min4. Treatment with any of the following, prior to first dose of trial treatment:4.1. Taxanes4.2. Any Investigational Medicinal Products (IMP) within 30 days 4.3. Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks4.4. Major surgery within 4 weeks4.5. Radiotherapy:4.5.1. With a wide field of radiation or involving >30% of total bone marrow volume, within 4 weeks4.5.2. With a limited field of radiation, for palliation, within 2 weeks5. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 (with the exception of alopecia) at the time of registration6. History of allergic reactions to any of the IMPs used in this trial7. Women who are pregnant or breast­feeding. Women of child­bearing potential must have a negative pregnancy test performed within 7 days prior to the start of trial treatment8. Men or women who are not prepared to practise methods of contraception of proven efficacy during treatment and for 6 months following the end of treatment9. Pre-existing tinnitus or hearing impairment ischaemic heart disease, cerebro­vascular disease, peripheral vascular disease or previous arterial embolic event

Recruitment start date

01/05/2015

Recruitment end date

01/11/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Cancer Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom